Chae Organics LLC
Form 483 issued March 14, 2025 · Walsenburg, Colorado
- Investigator
- Bryan L. McGuckin
- Observations
- 4
- Pages
- 25
- FEI number
- 3012026286
In short: On March 14, 2025, FDA issued a Form 483 with 4 observations to Chae Organics LLC in Walsenburg, Colorado (FEI 3012026286). The investigator was Bryan L. McGuckin. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no quality…
- 02
Specific identification tests are not conducted on components that have been accepted based on the…
- 03
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 04
There is no written assessment of stability of homeopathic drug products based at least on testing…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmChae Organics LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chae Organics LLC?
FDA listed 4 observations on this Form 483, mostly about quality system, materials and production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Chae Organics LLC?
Bryan L. McGuckin is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Chae Organics LLC inspected by FDA?
This Form 483 is dated March 14, 2025.
How do I get the full Form 483 for Chae Organics LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.